IMG-7289 in Patients With Myelofibrosis

Sponsor

Imago BioSciences,Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03136185

Collaborator

(none)

Enrollment

Locations

Arm

56.2

Actual Duration (Months)

17.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with myelofibrosis.

This study investigates the following:

The safety and tolerability of IMG-7289
The pharmacokinetics of IMG-7289 (performed in Phase 1/2a only)
The pharmacodynamic effect of IMG-7289

Condition or Disease	Intervention/Treatment	Phase
Myelofibrosis Post-polycythemia Vera Myelofibrosis (PPV-MF) Post-essential Thrombocythemia Myelofibrosis (PET-MF) Primary Myelofibrosis (PMF)	Drug: IMG-7289	Phase 2

Detailed Description

With enrollment complete in Phase 1/2a, expansion into Phase 2b has occurred. New patients will be enrolled into Phase 2b study.

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Mar 8, 2022

Actual Study Completion Date :

Mar 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMG-7289 Single starting dose with individualized dose titrations throughout	Drug: IMG-7289 Differentiation therapy Other Names: LSD1 inhibitor

Arm

Intervention/Treatment

Experimental: IMG-7289

Single starting dose with individualized dose titrations throughout

Drug: IMG-7289

Differentiation therapy

Other Names:

LSD1 inhibitor

Outcome Measures

Primary Outcome Measures

Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability] [Assessed from the time of first dose through 28 days after end of treatment.]
as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.

Secondary Outcome Measures

Drug Concentration (performed in Phase 1/2a only) [Up to 3 months.]
as measured by Cmin sampling.
Spleen Volume [Baseline to each visit where the variable is measured.]
Reduction in spleen volume based on MRI (or CT)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years
Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT
High or intermediate-2 risk disease, as defined per protocol

Exclusion Criteria:

Receiving other treatments for the condition (with exceptions and time limits)
Major surgery in last 4 weeks, minor surgery in the last 2 weeks
History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening
History of splenectomy
Current use of prohibited medications
A concurrent second active and nonstable malignancy
Known HIV infection or active Hepatitis B or Hepatitis C virus infection
Other hematologic/biochemistry requirements, as per protocol
Use of investigational agent within last 14 days
Pregnant or lactating females

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48105
2	Royal Adelaide Hospital	Adelaide	South Australia	Australia
3	Universitatsklinikum Essen	Essen		Germany	45147
4	Azienda Ospedaliero Universitaria Careggi	Florence		Italy
5	Guy's and St Thomas' Hospitals	London		United Kingdom